Catheter Placement for Hepatic Hydrothorax

NCT02595567 | Completed Results DMC

• 1 other identifier: 201108320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with liver disease. Despite medical therapy with diuretics and salt restriction, many patients still experience intractable, debilitating shortness of breath, often necessitating hospital admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is drained with a needle may be effective, but is often only temporary prior to the reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy.

Conditions

Pleural Effusion

Keywords

Liver disease; Pleural effusion

Outcome Measures

Primary Outcomes (1)

• Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax

  Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.

  From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months

Study Arms (1)

ITPC

OTHER

Device: Indwelling tunneled pleural catheter (ITPC)

Interventions

Indwelling tunneled pleural catheter (ITPC) DEVICE

ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions. Compared to the large amount of published data regarding the use of indwelling tunneled pleural catheters in malignant effusions, there is a paucity of data regarding the use of ITPC in liver disease for the treatment of hepatic hydrothorax.

ITPC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have recurrent pleural effusion due to underlying cirrhosis
• Subjects who are potential candidates for liver transplantation
• Subjects who are candidates for transjugular intrahepatic portosystemic shunt procedures
• Subjects who have had at least one thoracentesis in the past three months

You may not qualify if:

• Subjects with active bacterial or fungal infection
• Subjectswho are not potential candidates for transplantation
• Subjects with pleural effusions due to processes other than cirrhosis
• Subjects who are critically ill at the time of referral, requiring intensive care unit admission

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Universtiy

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Chen A, Massoni J, Jung D, Crippin J. Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax. A Pilot Study. Ann Am Thorac Soc. 2016 Jun;13(6):862-6. doi: 10.1513/AnnalsATS.201510-688BC.

  PMID: 27015392 DERIVED

MeSH Terms

Conditions

Pleural Effusion; Liver Diseases

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Alexander Chen, Director of Interventional Pulmonology
• Organization: Washington University School of Medicine

achen@dom.wustl.edu

314-454-8764

Study Officials

• Alexander C Chen, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Interventional Pulmonolgy, Assistant Professor of Medicine, Division of Pulmonary & Critical Care

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: November 3, 2015
• Study Start: October 1, 2010
• Primary Completion: July 20, 2015
• Study Completion: July 20, 2015
• Last Updated: May 8, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-04

Locations

US (1)